- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07689474
Balance-Cognitive-Strength Training for Balance, Inhibitory Control, and Gait in Preschool Children (BCS-Preschool)
Relationship Between Balance Ability and Gait Performance in Preschool Children: The Mediating Role of Inhibitory Control and Verification Through an Exercise-Cognitive Intervention
Study Overview
Status
Intervention / Treatment
Detailed Description
Preschool children aged 3 to 6 years were recruited from a kindergarten in Weifang, China. Eligible children completed baseline assessments of balance ability, gait performance, and inhibitory control. Balance was assessed using static and dynamic balance tasks on a Zebris force platform. Gait was assessed during single-task walking and dual-task walking while counting backward. Inhibitory control was assessed using an iPad-based Go/No-Go task.
Participants were randomly assigned to a balance-cognitive-strength training group or a usual daily activity control group. The training group received an 8-week exercise-cognitive integrated training program, 3 sessions per week and 40 minutes per session. Training activities included balance exercises, lower-limb strength activities, brisk walking games, and embedded cognitive tasks such as counting, verbal naming, memory tasks, and response inhibition tasks. The control group maintained usual daily activities during the same period.
Outcomes were assessed at baseline and immediately after the 8-week intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing, China, 100061
- China Institute of Sport Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 3 to 6 years.
- Children enrolled in the participating kindergarten in Weifang, China.
- Children able to understand and follow simple instructions for motor, gait, balance, and cognitive testing.
- Children able to participate in regular physical activity and complete the 8-week intervention or usual activity period.
- Written informed consent provided by a parent or legal guardian.
Exclusion Criteria:
- Diagnosed neurological, developmental, or motor disorder.
- Serious cardiovascular, respiratory, musculoskeletal, or other medical condition that would limit safe participation in physical activity.
- Lower-limb injury, deformity, or disease affecting standing, walking, balance, or jumping.
- Visual or hearing impairment that would prevent completion of the study tasks.
- Inability to complete the baseline assessments or comply with study procedures.
- Participation in another structured motor or cognitive intervention during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Balance-Cognitive-Strength Training
Participants received an 8-week exercise-cognitive integrated training program, 3 sessions per week and 40 minutes per session.
The program combined balance exercises, lower-limb strength activities, brisk walking or aerobic walking games, and embedded cognitive tasks involving counting, verbal naming, working memory, and response inhibition.
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The intervention was an 8-week exercise-cognitive integrated training program for preschool children.
Sessions were conducted 3 times per week, 40 minutes per session, at moderate intensity.
The program combined balance exercises, lower-limb strength activities, brisk walking or aerobic walking games, and embedded cognitive tasks involving counting, verbal naming, working memory, and response inhibition.
Other Names:
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No Intervention: Usual Daily Activities
Participants maintained their usual kindergarten and daily physical activities during the same 8-week period and did not receive the structured balance-cognitive-strength training program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change From Baseline in Single-Task Gait Index at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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The Single-Task Gait Index was derived from gait variables measured during normal walking.
Gait was assessed using a gait analysis system during single-task walking.
Variables included stance time, stride time, double-support time, step width variability, loading rate, and related temporal-spatial gait parameters.
Variables were standardized and direction-unified before construction of the gait index.
Higher scores indicate better single-task gait performance.
The change score was calculated as the post-intervention score minus the baseline score.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Dual-Task Gait Index at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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The Dual-Task Gait Index was derived from gait variables measured while children walked and performed a concurrent cognitive task.
During dual-task walking, participants walked while counting backward from 10 to 1. Variables included stance time, stride time, double-support time, step width variability, loading rate, and related temporal-spatial gait parameters.
Variables were standardized and direction-unified before construction of the gait index.
Higher scores indicate better gait performance under cognitive load.
The change score was calculated as the post-intervention score minus the baseline score.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Balance Composite Score at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Balance ability was assessed using static and dynamic balance tasks on a Zebris force platform.
The Balance Composite Score was constructed from standardized balance variables using principal component analysis.
The composite score reflected anterior-posterior sway control, load symmetry, and dynamic postural adjustment.
Negative indicators, such as center-of-pressure velocity and ellipse area, were direction-unified before score calculation.
Higher scores indicate better overall balance ability.
The change score was calculated as the post-intervention score minus the baseline score.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Inhibitory Control Composite Score at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Inhibitory control was assessed using an iPad-based Go/No-Go task from the Early Years Toolbox.
Children were instructed to respond to Go stimuli and inhibit responses to No-Go stimuli.
Accuracy and reaction time were standardized and direction-unified to create an inhibitory control composite score.
Higher scores indicate better inhibitory control.
The change score was calculated as the post-intervention score minus the baseline score.
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Baseline and immediately after the 8-week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change From Baseline in MABC-2 Total Test Standard Score at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Motor development was assessed using the Movement Assessment Battery for Children, Second Edition (MABC-2), age band 1 for children aged 3 to 6 years.
The total test standard score was derived from the manual dexterity, aiming and catching, and balance components.
Higher standard scores indicate better motor development.
The change score was calculated as the post-intervention score minus the baseline score.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in MABC-2 Manual Dexterity Component Score at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Manual dexterity was assessed using the MABC-2 age band 1 manual dexterity tasks, including fine motor tasks such as posting coins, threading beads, and drawing trail.
Scores were converted according to the MABC-2 scoring manual.
Higher component scores indicate better manual dexterity.
The change score was calculated as the post-intervention score minus the baseline score.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in MABC-2 Aiming and Catching Component Score at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Aiming and catching ability was assessed using the MABC-2 age band 1 aiming and catching tasks, including catching and throwing tasks.
Scores were converted according to the MABC-2 scoring manual.
Higher component scores indicate better ball skill and object-control performance.
The change score was calculated as the post-intervention score minus the baseline score.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in MABC-2 Balance Component Score at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Motor balance was assessed using the MABC-2 age band 1 balance tasks, including static and dynamic balance tasks such as one-leg balance, walking with heels raised, and jumping tasks.
Scores were converted according to the MABC-2 scoring manual.
Higher component scores indicate better balance-related motor development.
The change score was calculated as the post-intervention score minus the baseline score.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in 10-Meter Shuttle Run Time at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Agility and movement speed were assessed using the 10-meter shuttle run from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in seconds.
Lower values indicate better performance.
The change score was calculated as the post-intervention time minus the baseline time.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Standing Long Jump Distance at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Lower-limb explosive strength was assessed using the standing long jump from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in centimeters.
Higher values indicate better performance.
The change score was calculated as the post-intervention distance minus the baseline distance.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Tennis Ball Throw Distance at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Upper-limb power and object-control ability were assessed using the tennis ball throw from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in meters or centimeters according to the test record form.
Higher values indicate better performance.
The change score was calculated as the post-intervention distance minus the baseline distance.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Double-Foot Continuous Jump Time at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Coordination and lower-limb jumping ability were assessed using the double-foot continuous jump test from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in seconds.
Lower values indicate better performance.
The change score was calculated as the post-intervention time minus the baseline time.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Sit-and-Reach Distance at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Flexibility was assessed using the sit-and-reach test from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in centimeters.
Higher values indicate better flexibility.
The change score was calculated as the post-intervention distance minus the baseline distance.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Balance Beam Walking Time at Week 8
Time Frame: Baseline and immediately after the 8-week intervention
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Dynamic balance was assessed using the balance beam walking test from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in seconds.
Lower values indicate better performance.
The change score was calculated as the post-intervention time minus the baseline time.
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Baseline and immediately after the 8-week intervention
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CISS-20231110-BCS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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